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Distribution NIlotinib in semen in men treated for chronic Myeloid leukAemia


- candidate number28264
- NTR NumberNTR6886
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2017
- Secondary IDs2017.130 METc (VUmc)
- Public TitleDistribution NIlotinib in semen in men treated for chronic Myeloid leukAemia
- Scientific TitleDistribution NIlotinib in semen in men treated for chronic Myeloid leukAemia
- ACRONYMDANIMA
- hypothesisTo determine the level of nilotinib detectable in seminal fluid of men treated with this tyrosine kinase inhibitor And to form an advise if condoms are necessary to protect their sexual partners from exposure to nilotinib.
- Healt Condition(s) or Problem(s) studiedChronic Myeloid Leukemia (CML)
- Inclusion criteria male patients
aged >18 years
use of nilotinib for a minimal period of 1 month in chronic phase of CML
willing and capable of donating a semen sample for pharmacological analysis
- Exclusion criteria Refractory CML with persistent leucocytosis
Sterilisation
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2017
- planned closingdate1-dec-2018
- Target number of participants10
- InterventionsMales have to collect seminal fluid at two different time points with 1 month between collection points. Blood samples will be drawn at the same intervals, within one hour of collection of semen sample.
- Primary outcomePercentage of nilotinib present in seminal fluid in relation to the plasma concentration.
- Secondary outcomeCalculated maximal concentration nilotinib absorbed by the partner, using the volume of distribution of the tyrosine kinase inhibitors and the percentage in seminal fluid found in this study.
- Timepoints2 measure moments with 1 month in between
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc. M.A. Kuijvenhoven
- CONTACT for SCIENTIFIC QUERIESMsc. M.A. Kuijvenhoven
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryCML requires life-long treatment with nilotinib in most patients. As at least 25% of patients is below 40 years and life expectancy seems normal in well responding patients, sexualrelated issues are of major importance. Currently, use of condoms is advised for any male patient, in order to protect their sexual partners against TKI exposure. If this study shows very low and acceptable TKI levels in seminal fluid, condoms may no longer be required in cases where contraception is not needed.
The patients burden consists of two extra blood samples by Dried Blood Spot (DBS) and the effort of collecting and delivery of seminal fluid at two different time points. Patients may feel embarrassment with participation in the study.
- Main changes (audit trail)
- RECORD27-nov-2017 - 28-dec-2017


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